Obesity, Overweight
Conditions
Brief summary
The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks.
Detailed description
This is a phase Ⅲ, double-blind, randomised, placebo-controlled trial to assess the efficacy of HS-20094 in Chinese subjects with overweight or obesity. We enrolled adults (aged 18-65 years, both inclusive) with overweight (body-mass index \[BMI\] ≥24 kg/m2) accompanied by at least one obesity-related comorbidity or obesity (BMI ≥28 kg/m2) in China. Eligible participants were randomly assigned to receive once-weekly subcutaneous HS-20094 or placebo for 48 weeks. The co-primary endpoints were the percent change in bodyweight from baseline and the proportion of patients achieving weight loss≥5% from baseline after 48 weeks treatment.
Interventions
Administered SC
DRUGPlacebo injection
Administered SC
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 18 to 65 years of age at the time of consent(cutoff value included). * Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea. * Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.
Exclusion criteria
* Diabetes mellitus * Weight change \>5.0% after diet and exercise control for at least 12 weeks before screening * Have used or are currently using weight loss drugs within 3 months before screening * History of pancreatitis * Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2) * History of moderate to severe depression, or have a history of serious mental illness * Any lifetime history of a suicide attempt * Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions * Have a history of any malignancy within the past 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, week 48 | Percent Change from Baseline in Body Weight |
| Percentage of Participants Who Achieve weight loss≥ 5% from Baseline | Baseline, week 48 | Percentage of Participants Who Achieve weight loss≥ 5% from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline | Baseline, week 4 | Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline |
| Change in waist circumference from baseline at week 48 | Baseline, week 48 | Change in waist circumference from baseline at week 48 |
| Percentage change in body weight from baseline at week 24 | Baseline, week 24 | Percentage change in body weight from baseline at week 24 |
Countries
China
Outcome results
None listed